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FDA 510(k)

PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm

K-Number: K151228 · 2016-01-15

ApplicantEmerson & Co. Srl
Decision Date2016-01-15
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm is a medical device manufactured by Emerson & Co. Srl. It received FDA 510(k) clearance on 2016-01-15 under approval number K151228. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm?

PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm is a medical device that received FDA 510(k) clearance on 2016-01-15. It is manufactured by Emerson & Co. Srl. The 510(k) number is K151228.

When was PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm approved by the FDA?

PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm received FDA 510(k) clearance on 2016-01-15, under approval number K151228.

What company makes PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm?

PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm is manufactured by Emerson & Co. Srl.

What is the FDA product code for PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm?

The FDA product code for PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm is KGO.

Related Clinical Trials

NCT07607457 Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery NOT_YET_RECRUITING NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_RECRUITING NCT07589946 Integrated Medical, Surgical and Physiotherapy Care for Pregnant Women With Chronic Diseases COMPLETED NCT07557238 CHIP-CC Registry: A Prospective Multicenter Registry of Complex High-Risk PCI in China NOT_YET_RECRUITING NCT07185191 Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS) RECRUITING NCT07372638 Sensorised Surgical Gloves for Neuroendovascular Procedures NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40588707 Prescribing GLPs for Obesity Treatment for Adults at a University Based Health Maintenance Organization by Race, Ethnicity, and Socioeconomic Status. Journal of general internal medicine (2026)

Other Devices by Emerson & Co. Srl

K192933Polyisoprene Powder Free, Black Colour Surgical Gloves

Related Devices (Code: KGO)

K160928Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)Hartalega Sdb. Bhd. K160974Gammex Cut-Resistant Glove LinerAnsell Healthcare Products, LLC K161008POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVEHartalega Sdn Bhd K160875Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel CoatingCardinal Health, Inc. K153316Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)Cardinal Health, Inc. K152428SensiCare PI Surgical GlovesMedline Industries, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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